MAUDE Adverse Event Report: BECTON DICKINSON SODIUM CHLORIDE 0.9 % PERCENT; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3047938

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

Brown mark on end of saline flush noted prior to rn administration of saline, rn discarded saline flush and used a different syringe.

• Brand Name: SODIUM CHLORIDE 0.9 % PERCENT
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 17281910
• MDR Text Key: 318652908
• Report Number: MW5119195
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3047938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male